The Assembly Tech II will perform assembly processes on a variety of complex electro-mechanical and optically based sub-assemblies and finished medical devices while following Current Good Manufacturing Practices (cGMP). This position requires a high level of communication and proficient electromechanical skill set stemming from experience in a development environment. The Assembly Tech II will use a variety of tools and adhere to proper released build instructions and Quality System procedures, proper material handling, ESD procedures, and more. All Assembly Technicians are also responsible for following good documentation practices (GDP) and performing all required electronic systems transactions accurately and in real time. The Assembly Tech II may train other Assembly Technicians.
Duties and Responsibilities
- Assembles, tests, troubleshoots, and repairs significantly complex electrical and mechanical prototype subassemblies and final assemblies per written specifications or engineering-level documentation and / or verbal instructions.
• Provide hands-on troubleshooting, guidance and some problem-solving support within development engineering as needed. Assist Engineering in determining root cause and subsequent analysis.
• Expectation for this position requires ability to perform moderate to high complexity tasks with minimal oversight.
• Organize and maintain prototyping build and test environments, and engineering workstations, to ensure tools and equipment are available, inventoried, organized, tracked, stored, maintained and replaced/expanded as driven by project needs.
• Assist Development Engineers with revisions and improvements to build and test procedures.
- May transition between multiple product lines within a short period of time.
- Some light testing / calibration could be required.
- Performs training to other Assembly Technicians as required.
- Completes manufacturing documentation as outlined in the work order / Device History Record package.
- Performs all transactions in Cogmedix electronic business systems accurately in real time, and understands cause and effect of the transactions.
- Packages final product per written specifications.
- Identifies and reports any product quality problems or discrepancies.
- Documents non-conformances.
- Responsible for following cGMP and ISO 13485 requirements.
- Maintain proper control of device traceability materials and non-conforming material.
- Qualifications
- Experience in electro-mechanical and opto-mechanical assembly required.
- Experience in basic manufacturing methods required.
- Experience in medical device manufacturing preferred.
- Experience using torque tools, epoxy, epoxy dispensing tools, tubing heat shrink required.
- Superior customer (internal and external) service attitude.
- Excellent teamwork and communication skills.
- High School Diploma or equivalent. Certain work experience may be considered in lieu of educational requirements.
- Ability to multi-task and cross among several product lines in a short period of time required.
- Must be able to read, write, and comprehend detailed manufacturing procedures and drawings in English.
- A demonstrated commitment to company values.
- Excellent manual dexterity and eye/hand coordination.
Cogmedix is an Equal Opportunity Employer. Cogmedix does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.